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510(k) Data Aggregation

    K Number
    K110735
    Device Name
    TANDA MAX OTC SYSTEM
    Manufacturer
    PHAROS LIFE CORPORATION
    Date Cleared
    2011-08-03

    (140 days)

    Product Code
    OHS, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHAROS LIFE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tända Max OTC System is intended to be used for the treatment of wrinkles, rhytides, and fine lines in the periorbital region.
    Device Description
    The Tända Max OTC System is a modular system that offers simplicity in use and convenience. The system can operate while connected directly to an electrical outlet or can be used in cordless mode drawing upon its rechargeable batteries to deliver the treatment. The system components include the control unit, the treatment head, recharging stand, AC adapter, and goggles. The Tända Max OTC System utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.
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    K Number
    K103415
    Device Name
    TANDA MAX
    Manufacturer
    PHAROS LIFE CORPORATION
    Date Cleared
    2011-01-03

    (42 days)

    Product Code
    ONE
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHAROS LIFE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tända Max System is intended for the treatment of wrinkles, rhytides and fine lines in the periorbital region.
    Device Description
    Tända Max is a modular system that offers simplicity in use and convenience. The system can operate while connected directly to an electrical outlet or can be used in cordless mode drawing upon its rechargeable batteries to deliver the treatment. The system components include the control unit, the treatment head, recharging stand, Pre-treatment gel, AC adapter and goggles. Tända Max utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.
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    K Number
    K090008
    Device Name
    TANDA RESTORE, MODEL PTSCS
    Manufacturer
    PHAROS LIFE CORPORATION
    Date Cleared
    2009-10-15

    (286 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHAROS LIFE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tända Restore System is an over-the-counter device intended for use whenrever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional for the purpose of providing temporary relief of minor aches and pains in muscles and joints. Tända Restore is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature. Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness. Provides temporary relief of minor aches and pains in muscles and joints. Aids in the relaxation of muscles. Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief. Provides a temporary increase in local blood circulation.
    Device Description
    The Tanda Restore is a modular platform which supports and infrared lamp (LED Array Head) for the purposes of applying infrared heat to the human body. It consists of LED infrared lamps emitting infrared energy in the wavelength of 870 nm.
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    K Number
    K080591
    Device Name
    TANDA SKINCARE SYSTEM, MODEL: PTSCS
    Manufacturer
    PHAROS LIFE CORPORATION
    Date Cleared
    2008-11-14

    (256 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHAROS LIFE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tända Skincare System is intended as an over-the-counter phototherapy device for the treatment of mild to moderate acne. The Tanda Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
    Device Description
    The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.
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    K Number
    K070185
    Device Name
    TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001
    Manufacturer
    PHAROS LIFE CORPORATION
    Date Cleared
    2007-08-21

    (214 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHAROS LIFE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tända Skincare System is a device intended to administer phototherapeutic light to the body in order to treat Acne. The tända Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
    Device Description
    The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.
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